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Xbrane Biopharma has withdrawn the BLA (Biologics License Application) for its investigational biosimilar candidate to Lucentis after receiving feedback from the FDA that complementary information is required for the FDA to take the decision to accept the BLA and initiate the review. Xbrane will Already a subscriber Login You have…
Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. This marks the first regulatory approval for a type I interferon (type I IFN) receptor antagonist and the onlyAlready a subscriber Login You…
The company has been awarded a grant from the Swedish innovation programs, SWElife and MedTech4Health in a collaboration with Danderyd hospital, Huddinge hospital and Karolinska Institute. The grant will fund a further clinical trial of its antibiotic free treatment pHyph for the treatment of vulAlready a subscriber Login You have…
The company has received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency (EMA) for the company’s lead cancer relapse vaccine candidate, DCP-001. DCP-001 is derived from Immunicum’s human DCOne cell line and is currently being evaluated as a cancer rAlready a subscriber Login You have read all…
